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Tablet Dissolution Testers

Dissolution, in simple words, is the process of dissolving or breaking apart. A dissolution test is performed to measure the rate and scope of drug release from a dosage form such as capsule, tablets, ointment etc.There are seven different types of test methods for Dissolution as per United States Pharmacopeia (USP), which is the primary regulatory authority.Each type of dissolution test procedure will have a method and a type of dissolution test tester associated with it.As a trusted name in analytical instruments, we provide various types of dissolution testers that comply with all current USP regulations.Our range of Dissolution testers are designed to comply with USP 1,2,5 & 6 and the latest BP, EP, IP & USP specifications.We not only provide you with a dissolution test apparatus but also provide a dissolution tester calibration toolkit for inhouse calibration.The dissolution toolkit is intended for mechanical calibration of the dissolution tester as per the current pharmacopeia guidelines.

I. Introduction to Dissolution Testing

  • Applications of Dissolution Testing in Different Industries


Here are some examples of how dissolution testing is applied in different industries:


  • Pharmaceutical Industry: Dissolution testing is extensively used in the pharmaceutical industry to assess the quality and performance of drug formulations. It is an essential tool for determining the dissolution rate of drugs in the gastrointestinal tract and how efficiently they are absorbed into the bloodstream. The dissolution test results can also help to optimize drug formulations, evaluate the impact of manufacturing process changes, and ensure the stability of the drug product over time.

  • Food Industry: Dissolution testing is used to measure the solubility and release properties of various food ingredients, such as vitamins, minerals, and flavorings. It is also used to evaluate the effectiveness of food preservatives and the stability of food additives under different storage conditions.

  • Chemical Industry: Dissolution testing is commonly used in the chemical industry to assess the solubility and release properties of various chemicals, such as pesticides, fertilizers, and detergents. It is also used to evaluate the effectiveness of water treatment chemicals and the stability of industrial additives

  • Environmental Industry: Dissolution testing can be applied in environmental monitoring to assess the solubility and release of pollutants, such as heavy metals and organic compounds, from contaminated soil and water samples. It can also be used to evaluate the effectiveness of remediation techniques and the stability of environmental monitoring equipment.

Overall, dissolution testing is a versatile analytical technique that plays a critical role in various industries, helping to ensure product quality, performance, and safety.

II. Components of a Dissolution Tester

  • Types of Dissolution Testers


There are several types of dissolution testers available, including:


  • Dissolution Test Apparatus 1 (Basket Apparatus): This type of dissolution tester is designed to test immediate-release formulations, where the drug is released quickly. A tablet or capsule is placed in a basket and immersed in a liquid medium, and the rate of drug release is monitored.

  • Dissolution Test Apparatus 2 (Paddle Apparatus): This type of dissolution tester is used to test formulations that release the drug more slowly. A tablet or capsule is placed in a vessel containing a liquid medium, and a paddle is used to stir the medium to simulate the mechanical agitation of the stomach. The rate of drug release is then measured.

  • Dissolution Test Apparatus 3 (Reciprocating Cylinder): This type of dissolution tester is designed to simulate the movement of the small intestine. A tablet or capsule is placed in a cylindrical vessel, which moves back and forth to simulate the peristaltic motion of the small intestine. The rate of drug release is monitored.

  • Dissolution Test Apparatus 4 (Flow-through Cell): This type of dissolution tester is used to test formulations that are poorly soluble or insoluble in water. The tablet or capsule is placed in a flow-through cell, and a constant flow of a dissolution medium is passed over it. The rate of drug release is measured by monitoring the concentration of the drug in the effluent stream.

  • Dissolution Test Apparatus 5 (Paddle Over Disc): This type of dissolution tester is designed to test transdermal patches or other drug delivery systems that release the drug through a membrane. The drug delivery system is placed between a paddle and a stationary disc, and a liquid medium is circulated over the membrane. The rate of drug release is monitored.

  • Miniaturized Dissolution Tester: This type of dissolution tester is a smaller version of the traditional apparatus, allowing for a smaller sample size and reduced solvent usage. These testers are ideal for early-stage development and optimization of drug formulations.

Each type of dissolution tester has its advantages and disadvantages, and the selection of the appropriate apparatus depends on the specific drug formulation being tested and the requirements of the regulatory agency.

III. Dissolution Testing Methodology

  • Sample Preparation


Dissolution testing involves measuring the rate at which a drug substance dissolves from a solid dosage form into a dissolution medium, typically water or a buffered solution. Proper sample preparation is essential for obtaining accurate and reliable dissolution test results. Here are some important considerations for sample preparation in dissolution testing


  • Selection of the dissolution medium: The choice of the dissolution medium depends on the solubility and stability of the drug substance in different media. The medium should be physiologically relevant and should maintain a consistent pH throughout the test.

  • Preparation of the dissolution medium: The dissolution medium should be prepared according to the method specified in the pharmacopeia or as per the validated procedure. It should be filtered and degassed before use to remove any particulate matter or dissolved gases that could affect the test results.

  • Sampling: The amount of sample used in dissolution testing should be representative of the drug product and should be accurately weighed or measured. Sampling should be done using a sampling thief or cannula to avoid introducing air bubbles into the medium.

  • Apparatus selection: The type of dissolution apparatus used depends on the characteristics of the drug product, the volume of the medium, and the desired test conditions. Commonly used apparatuses include USP Apparatus 1 (Basket), Apparatus 2 (Paddle), and Apparatus 3 (Reciprocating Cylinder).

  • Calibration: The dissolution apparatus should be calibrated as per the pharmacopeial requirements before use. The calibration should include verification of the speed of rotation, temperature, and volume of the dissolution medium.

  • Sample placement: The sample should be placed in the appropriate position in the dissolution apparatus to ensure that it is fully exposed to the dissolution medium. The position should be verified before the test begins.

  • Testing conditions: The testing conditions, including temperature, agitation speed, and sampling interval, should be set as per the pharmacopeial requirements or validated method. These conditions should be maintained throughout the test.

By following these considerations, one can ensure proper sample preparation and obtain accurate and reliable dissolution test results.

  • Test Conditions


Dissolution testing is a vital quality control test used in the pharmaceutical industry to evaluate the release of active drug substances from solid dosage forms such as tablets, capsules, and powders. The conditions of dissolution testing methodology are critical as they can significantly impact the results of the test. Here are some of the critical parameters that must be considered when developing dissolution testing methodology:


  • Medium: The choice of the dissolution medium should simulate the physiological conditions of the target site of absorption. The medium should be carefully selected to ensure that it can adequately solubilize the drug substance.

  • Temperature: The temperature of the dissolution medium should be maintained at a constant temperature, which is typically 37 ± 0.5 to simulate the temperature of the human body.

  • Rotation speed: The rate of rotation of the dissolution apparatus should be carefully controlled. The USP recommends a rotation speed of 50 rpm for the paddle method and 100 rpm for the basket method.

  • Sampling intervals: The sampling intervals should be determined based on the characteristics of the dosage form, the dissolution medium, and the drug substance being tested. Generally, samples should be taken at regular intervals and analyzed for drug content.

  • Volume of the dissolution medium: The volume of the dissolution medium should be sufficient to ensure sink conditions, which means that the concentration of the drug substance in the dissolution medium remains low enough to prevent saturation.

  • Duration of the test: The duration of the dissolution test should be sufficient to ensure complete drug release from the dosage form. The USP recommends testing for a minimum of 30 minutes and up to 120 minutes.

  • Dissolution Test Apparatus: There are different types of dissolution apparatus, such as the paddle and basket methods. The selection of the apparatus should be based on the characteristics of the dosage form and the drug substance being tested.

It is important to note that the dissolution testing methodology should be validated to ensure the accuracy, reproducibility, and reliability of the results. Validation involves verifying that the method is suitable for its intended use, and that the results are consistent and accurate.

  • Sampling Procedure


The sampling procedure in dissolution testing is essential to ensure the accuracy and precision of the results obtained. The following steps outline the general sampling procedure in dissolution testing methodology:


  • Sampling time points: Select the appropriate time points for sampling based on the dissolution profile of the drug substance. Typically, samples are collected at different intervals, such as 5, 10, 15, 20, 30, 45, or 60 minutes.

  • Sampling volume: Determine the appropriate sampling volume for each time point. The volume should be large enough to ensure accuracy but small enough to minimize the impact on the dissolution profile

  • Sampling location: Identify the appropriate sampling location in the dissolution apparatus. Generally, the sampling probe is placed in the center of the vessel, and the depth is about 1 cm below the surface of the medium.

  • Sample collection: Collect the samples using a sampling probe or syringe. The sampling probe or syringe should be rinsed with the dissolution medium before each sample collection to prevent contamination.

  • Sample preparation: Transfer the collected sample to a suitable container and prepare it for analysis. Depending on the analytical method used, the sample may require filtration, dilution, or other preparation steps.

  • Analysis: Analyze the prepared sample using the appropriate analytical method. Common methods include UV-Vis spectroscopy, high-performance liquid chromatography (HPLC), or gas chromatography (GC).

  • Data interpretation: Interpret the analytical data to determine the dissolution rate of the drug substance at each time point.

Overall, a well-designed sampling procedure is essential for accurate and reliable dissolution testing results. The procedure should be optimized to minimize variability and ensure consistency across different time points and batches.

IV. Calibration and Validation of Dissolution Testers

  • Calibration of Dissolution Testers


Calibration of dissolution testers is necessary to ensure accurate and reliable measurements. The calibration procedure involves several steps


  • Verification of the electrical supply: The voltage and current output of the electrical supply to the dissolution tester should be checked using a multimeter to ensure that it meets the manufacturer's specifications.

  • Temperature verification: The temperature of the dissolution medium should be checked using a calibrated thermometer to ensure that it is within the specified range.

  • Verification of the rotation speed: The rotation speed of the paddle or basket should be verified using a stroboscope or tachometer to ensure that it is within the specified range.

  • Verification of the sampling apparatus: The volume of the sampling apparatus should be checked using a calibrated measuring cylinder to ensure that it is accurate.

  • Verification of the dissolution medium volume: The volume of the dissolution medium should be checked using a calibrated measuring cylinder to ensure that it is accurate.

  • Verification of the calibration standard: A calibration standard with a known dissolution rate should be used to verify the accuracy of the dissolution tester.

  • Data analysis: The data obtained from the calibration procedure should be analyzed using statistical methods to ensure that the dissolution tester is performing within the acceptable range of accuracy and precision.

The calibration of dissolution testers should be performed periodically according to the manufacturer's recommendations or as required by regulatory agencies. Calibration records should be maintained to document the calibration procedure, results, and any corrective actions taken.

  • Validation of Dissolution Testers


To ensure the accuracy and reliability of dissolution test results, it is crucial to validate dissolution testers before use. Here are some general guidelines for validating dissolution testers:


  • Equipment qualification: The first step in validating dissolution testers is to ensure that the equipment is qualified. This involves verifying that the instrument is properly installed, calibrated, and maintained. It is important to follow the manufacturer's instructions and recommendations for equipment qualification.

  • Performance verification: Once the equipment is qualified, performance verification tests should be conducted. This involves running a series of tests using a standard sample, and verifying that the results are within acceptable limits. The acceptance criteria should be established in advance and should be based on regulatory guidelines and industry standards.

  • System suitability: System suitability tests should be performed to ensure that the dissolution tester is capable of producing consistent and accurate results over time. This involves running a series of tests regularly, using a standard sample, and verifying that the results are within acceptable limits.

  • Method validation: Before using the dissolution tester for analysis, the analytical method used for the analysis should be validated. The validation should include testing the method's specificity, accuracy, precision, linearity, range, and robustness.

  • Documentation: It is important to document all validation activities, including equipment qualification, performance verification, system suitability, and method validation. The documentation should include the acceptance criteria used, the results of the tests, and any corrective actions taken.

By following these guidelines, pharmaceutical companies can ensure that their dissolution testers are properly validated and produce accurate and reliable results.

V. Dissolution Testing Data Analysis

  • Calculation of Dissolution Results


Dissolution is a process in which a solid substance dissolves in a liquid solvent to form a solution. The dissolution process can be measured and analyzed to determine the extent of dissolution and the rate at which it occurs. To calculate dissolution results, the following parameters are typically measured and analyzed:


  • Dissolution rate: This is the rate at which the solid substance dissolves in the solvent. It is typically measured as the amount of substance dissolved per unit of time and is expressed in units such as mg/min, mg/hr, or %/min.

  • Dissolution efficiency: This is the extent to which the solid substance dissolves in the solvent. It is typically expressed as a percentage of the total amount of substance added that dissolves, and is calculated as follows:
    Dissolution efficiency (%) = (Amount of substance dissolved / Total amount of substance added) x 100

  • Dissolution profile: This is a graph of the amount of substance dissolved over time. It provides information on the rate and extent of dissolution and can be used to compare the dissolution properties of different formulations or batches of the same substance.

To calculate these parameters, a dissolution test is typically conducted using a standardized apparatus and method. The test involves placing a known amount of the solid substance in a dissolution vessel containing a specified volume of solvent and measuring the amount of substance dissolved at various time points. The results are then analyzed using appropriate statistical methods to determine the dissolution rate, efficiency, and profile.

  • Statistical Analysis of Dissolution Data


Statistical analysis of dissolution data is an important step in evaluating the performance of pharmaceutical products. Dissolution testing is used to determine the rate at which a drug substance dissolves in a specified medium, and it is an important quality control test for solid oral dosage forms. The following are some common statistical methods used in the analysis of dissolution data:


  • Descriptive Statistics: Descriptive statistics are used to summarize the central tendency, variability, and distribution of dissolution data. Measures of central tendency include the mean, median, and mode, while measures of variability include the standard deviation, range, and coefficient of variation. Descriptive statistics can help identify outliers and provide a visual representation of the data.

  • Analysis of Variance (ANOVA): ANOVA is used to compare the means of two or more groups. In dissolution testing, ANOVA can be used to compare the mean dissolution values for different formulations or batches of a drug product. ANOVA can help determine if there are statistically significant differences between the groups and can provide information on the variability within each group.

  • Regression Analysis: Regression analysis is used to examine the relationship between two or more variables. In dissolution testing, regression analysis can be used to determine the relationship between dissolution rate and time or other factors that may affect dissolution, such as pH or temperature.

  • Confidence Intervals: Confidence intervals provide a range of values that is likely to contain the true mean value of a population based on a sample. In dissolution testing, confidence intervals can be used to determine the precision of the dissolution method and the variability of the dissolution data.

  • Hypothesis Testing: Hypothesis testing is used to determine if there is a significant difference between two groups or if a relationship exists between two variables. In dissolution testing, hypothesis testing can be used to determine if there is a significant difference between the dissolution profiles of two drug products or if a relationship exists between the dissolution rate and a specific factor, such as pH.

In conclusion, statistical analysis of dissolution data is an important tool for evaluating the performance of pharmaceutical products. The methods described above can provide valuable information on the central tendency, variability, and distribution of dissolution data, and can help identify differences between formulations or batches of a drug product. In addition to these methods, it is important to ensure that the dissolution data is accurate, precise, and reproducible. This can be achieved through appropriate sampling and testing procedures, careful measurement and recording of data, and appropriate statistical analysis of the data.

  • Acceptance Criteria for Dissolution Testing


Acceptance criteria for dissolution testing is a set of predetermined standards used to determine the quality of a drug product. The acceptance criteria for dissolution testing may vary depending on the specific drug product, dosage form, and regulatory requirements. However, some general acceptance criteria for dissolution testing may include:


  • The drug product should meet the dissolution requirements specified in the United States Pharmacopeia (USP) or other relevant pharmacopeias.

  • The drug product should meet the dissolution profile specified in the product labeling.

  • The dissolution test results should be consistent and reproducible within a certain level of variability.

  • The dissolution test method should be validated and demonstrate appropriate sensitivity, specificity, and accuracy.

  • The dissolution test should be performed under appropriate conditions, including temperature, pH, and agitation rate.

  • The drug product should demonstrate a certain level of dissolution at specific time points to ensure that the drug will be absorbed by the body.

  • The acceptance criteria for dissolution testing should be based on scientific and clinical data.

In summary, acceptance criteria for dissolution testing should be well-defined, scientifically justified, and consistent with regulatory requirements to ensure the quality, safety, and efficacy of the drug product.

VI. Factors Affecting Dissolution Testing

  • Physicochemical Properties of the Drug Substance


The physicochemical properties of the drug substance can affect its dissolution rate and, consequently, its bioavailability and therapeutic efficacy. Some of the physicochemical properties that can influence dissolution testing include:


  • Solubility: The solubility of a drug substance is the maximum amount that can dissolve in a given solvent at a specific temperature and pressure. Drugs with high solubility will dissolve quickly and completely, resulting in a rapid dissolution rate, while drugs with low solubility may dissolve slowly and incompletely, resulting in a slow dissolution rate.

  • Particle size: The particle size of the drug substance can affect its surface area and the rate at which it dissolves. Smaller particle sizes have a larger surface area-to-volume ratio, allowing them to dissolve more quickly than larger particles.

  • Crystal form: The crystal form of a drug substance can also affect its dissolution rate. Different crystal forms of the same drug substance may have different solubilities, which can impact their dissolution rates.

  • Polymorphism: Polymorphism is the ability of a drug substance to exist in different crystal forms. Different polymorphic forms of a drug substance can have different solubilities and dissolution rates.

  • Hygroscopicity: Hygroscopicity refers to the ability of a drug substance to absorb moisture from the surrounding environment. Hygroscopic drugs can become sticky and clump together, which can affect their dissolution rates.

  • pH: The pH of the dissolution medium can affect the ionization state of the drug substance and its solubility, which can influence its dissolution rate.

  • Temperature: The temperature of the dissolution medium can also affect the solubility and dissolution rate of a drug substance. Higher temperatures can increase the solubility and dissolution rate of some drugs, while lower temperatures can decrease them.

Overall, understanding the physicochemical properties of a drug substance is essential in designing appropriate dissolution tests and ensuring the quality and effectiveness of pharmaceutical products.

  • Formulation Factors


Formulation factors play an important role in dissolution testing, which is a critical step in drug development and quality control. Some of the key formulation factors that can affect dissolution testing include:


  • Drug properties: The physicochemical properties of the drug, such as solubility, crystal form, particle size, and polymorphism, can influence the dissolution rate and affect the release of the drug from the formulation.

  • Excipients: Excipients are non-active ingredients that are added to the formulation to enhance stability, bioavailability, and patient compliance. The choice and concentration of excipients can affect the dissolution rate of the drug, as well as its solubility and stability.

  • Manufacturing process: The manufacturing process can impact the physical and chemical properties of the drug and its formulation, which can affect the dissolution rate and drug release. For example, the use of high shear forces during granulation can lead to changes in particle size and distribution, which can impact dissolution.

  • Dosage form: The type of dosage forms, such as tablet, capsule, or solution, can also affect dissolution testing. The formulation of each dosage form can have unique characteristics that impact dissolution, such as the presence of disintegrants or the ability to form a gel matrix.

  • pH and media: The pH of the dissolution media can affect the solubility and stability of the drug and formulation, as well as the rate of dissolution. The choice of media can also impact dissolution, as some media may be more or less suitable for certain drugs or formulations.

Overall, formulation factors are important considerations in dissolution testing and can impact the quality, safety, and efficacy of drug products. Careful consideration of these factors can help ensure that dissolution testing accurately reflects the performance of the drug in vivo.

VII. Troubleshooting in Dissolution Testing

  • Common Problems in Dissolution Testing


Several factors can affect the accuracy and reliability of dissolution testing, leading to common problems. Some of these problems include:


  • Inadequate dissolution media: The selection of dissolution media is critical in the dissolution testing process. The media must simulate the physiological conditions of the gastrointestinal tract and ensure that the drug is released from the dosage form. The media's pH, temperature, and ionic strength must be appropriate for the drug being tested. Inadequate or inappropriate dissolution media can result in incomplete or erratic drug release, leading to inaccurate dissolution profiles.

  • Poor sample preparation: The sample preparation process can also affect the accuracy of dissolution testing. The dosage form must be properly disintegrated and homogenized to ensure uniformity in drug content and particle size distribution. Poor sample preparation can lead to variations in drug release rates, leading to inaccurate dissolution profiles.

  • Equipment issues: Equipment used in dissolution testing must be properly maintained and calibrated. Mechanical issues, such as an improper paddle or basket positioning, can result in inconsistent dissolution profiles. Electronic issues, such as malfunctioning temperature probes or timer settings, can also affect dissolution testing accuracy.

  • Interference from excipients: Excipients in the dosage form can sometimes interfere with dissolution testing, leading to inaccurate dissolution profiles. Excipients that affect the solubility or stability of the drug can lead to incomplete or erratic drug release. In some cases, the excipients themselves can dissolve, leading to inaccurate dissolution profiles.

  • Sample collection and analysis: The collection and analysis of dissolution samples are critical steps in dissolution testing. Samples must be collected at appropriate time intervals to capture the drug release profile accurately. The analytical method used to quantify the drug in the sample must be sensitive and specific. Inaccurate sample collection or analysis can lead to erroneous dissolution profiles.

Overall, dissolution testing is a complex process that requires careful attention to detail to ensure accurate and reliable results. By addressing these common problems, dissolution testing can be an invaluable tool in drug development and quality control.

  • Causes and Solutions


Here are some causes and solutions to problems in dissolution testing:


  • Equipment-related problems: Equipment-related problems may arise due to equipment malfunctioning, equipment not being properly calibrated, or equipment not being cleaned properly. These problems can lead to inaccurate results.
    Solution: Regular maintenance, calibration, and cleaning of the equipment are necessary to ensure accurate and reliable results.

  • Sample-related problems: Sample-related problems can occur when the sample is not properly prepared, or when the sample is not representative of the drug product being tested.
    Solution: Proper sample preparation and selection are essential in ensuring accurate results.

  • Media-related problems: Media-related problems can arise due to incorrect pH, inappropriate media composition, or temperature fluctuations.
    Solution: Proper selection and preparation of the dissolution medium are necessary to ensure accurate and reliable results.

  • Method-related problems: Method-related problems can occur due to errors in the method used for testing, such as inappropriate sampling intervals or agitation speed.
    Solution: The dissolution method should be properly validated, and the operator should be properly trained in the method used.

  • Operator-related problems: Operator-related problems can occur due to errors in handling the equipment or sample, or due to insufficient training of the operator.
    Solution: Proper training and supervision of the operator are necessary to ensure accurate and reliable results.

In conclusion, dissolution testing is a critical process in drug development, and it is important to address any problems that arise. By identifying the causes of the problems and implementing appropriate solutions, accurate and reliable results can be obtained, which will ultimately lead to the development of safe and effective drugs.

VIII. Future Directions in Dissolution Testing

Dissolution testing is an important analytical technique used in the pharmaceutical industry to evaluate the dissolution behavior of drug formulations. It involves measuring the rate and extent of drug release from a dosage form into a dissolution medium under standardized conditions. As the pharmaceutical industry evolves and new drug delivery technologies emerge, several future directions in dissolution testing are worth considering.


  • In vitro-in vivo correlation (IVIVC): IVIVC is a technique used to establish a correlation between the in vitro dissolution performance of a drug product and its in vivo performance. IVIVC can be used to predict the in vivo behavior of a drug product based on its in vitro dissolution data, and vice versa. The development of IVIVC models can facilitate the establishment of biowaivers and streamline the drug development process.

  • Use of biorelevant media: Biorelevant media are dissolution media that simulate the physiological conditions of the gastrointestinal tract. They can provide a more accurate prediction of the in vivo dissolution behavior of a drug product compared to conventional dissolution media. The use of biorelevant media can enhance the relevance and predictability of dissolution testing.

  • Automation and robotics: Automation and robotics can improve the efficiency and reliability of dissolution testing. Automated systems can reduce the variability associated with manual sampling and data analysis, and improve data quality and reproducibility.

  • Real-time monitoring: Real-time monitoring of dissolution testing can provide a more comprehensive understanding of the dissolution behavior of drug products. Real-time monitoring techniques such as near-infrared spectroscopy (NIRS) and Raman spectroscopy can provide rapid and non-destructive measurements of drug concentration in the dissolution medium.

  • Quality by design (QbD) approach: QbD is a systematic approach to pharmaceutical development that emphasizes product and process understanding and control. QbD principles can be applied to dissolution testing to ensure that the testing method is robust, reliable, and provides relevant data.

  • In situ dissolution testing: In situ dissolution testing involves measuring the dissolution behavior of a drug product directly within the dosage form. This technique can provide a more accurate representation of the dissolution behavior of a drug product in vivo.

  • Combination products: Combination products that contain two or more active pharmaceutical ingredients (APIs) present unique challenges for dissolution testing. The development of dissolution testing methods for combination products is an important future direction.

Overall, the future of dissolution testing will involve the integration of new technologies and approaches to enhance the relevance, efficiency, and predictability of dissolution testing in drug development and quality control.




FAQ Section

1.What is the use of the dissolution apparatus?

An important aspect of the product development process is dissolution testing. In vitro conduction, Dissolution apparatuses used for this purpose are widely used in industry to study the dissolution profile of drugs in physiological or prototypical conditions. The capability of the apparatus is defined by its accuracy and precision, its throughput and speed, as well as by its reliability and reproducibility. Then after passing or approval from the Quality control and Quality assurance, drugs are sent to markets.

2. How do you perform a dissolution test for tablets?

Dissolution testing is the process of determining how well a drug is absorbed by the body after it's taken, and it can be performed on tablets. To do this, Follow steps are performed

  • 1. Warm the dissolution medium to 36.5 to 37.5
  • 2. Place one dosage unit in the apparatus, cover the vessel, and operate the apparatus at the specified parameter (Time, RPM, Temp condition)
  • 3. After 2 hours of operation in the acid medium, withdraw an aliquot of the liquid and proceed immediately as directed under the Buffer stage for the % of drug release test.

3.How does a dissolution tester work?

A dissolution tester works by simulating the conditions in which a drug is released from its dosage form into an aqueous solution, usually simulating the conditions in the human body. The tester measures the rate and extent of drug release over a specified time period, providing information on the drug's bioavailability and performance. The tester typically consists of a vessel that holds the dissolution medium and the drug dosage form, a stirring mechanism to agitate the solution, and a device to measure the concentration of the drug in the solution over time.

4.What are the types of dissolution tests apparatus as per USP?

There are several types of dissolution tests apparatus as per USP including:

  • USP-Basket method: used for solid dosage forms such as tablets and capsules.
  • USP-Paddle method: used for semisolid and solid dosage forms.
  • USP-Reciprocating cylinder method: used for solid and semisolid dosage forms.
  • USP-Flow-through cell method: used for suspensions and solid dosage forms.
  • USP-(paddle over disk): used for solid dosage forms.
  • USP- Rotating cylinder

Each method has its own advantages and limitations, and the choice of method depends on the type of drug, dosage form, and desired information.

5. Which tablets are used in the calibration of dissolution test apparatus prednisone?

Tablets used in the calibration of a dissolution test apparatus are typically reference standards or commercially available tablets with known dissolution characteristics. Examples of such tablets include USP (United States Pharmacopeia) reference standards, such as prednisone, and other quality control tablets, such as those used in in-house quality control procedures. The choice of tablet depends on the type of dissolution apparatus and the type of drug being tested. It is important to use tablets with known and consistent dissolution properties to ensure accurate and reliable results.

6. How many tablets are used in the dissolution test?

The number of tablets used in a dissolution test can vary, depending on the specific test requirements and the type of drug being tested. In general, six tablets is recommended to obtain a representative sample and to account for variability within a batch. The number of tablets used can be increased to increase the accuracy and precision of the results, but this will also increase the cost and time required for the test. The exact number of tablets used in a dissolution test should be determined based on regulatory requirements, industry standards, and the specific needs of the study.

7. What are the types of tablet testing?

There are several types of tablet testing, including:

Physical testing: evaluating the physical properties of tablets, such as size, shape, hardness, friability, and disintegration.

  • Physical testing:evaluating the physical properties of tablets, such as size, shape, hardness, friability, and disintegration.
  • Chemical testing:analyzing the chemical composition and purity of the active ingredient and excipients in the tablet.
  • Dissolution testing:determining the rate and extent of drug release from the tablet into an aqueous solution.
  • Bioequivalence testing:comparing the performance of a test product to an approved reference product.
  • Stability testing:evaluating the stability and shelf-life of the tablet under specified storage conditions.
  • Each type of tablet testing serves a different purpose and provides important information about the quality and performance of the tablet. The specific tests performed on a tablet will depend on the type of drug, the intended use, and regulatory requirements.